Bone Marrow Transplant (BMT)
Bone Marrow Transplant (BMT)
1
| Disease Status and/or Stage | Multiple Myeloma |
|---|---|
| Protocol Title | CALGB 100104: A Phase III Randomized, Double-Blind Study of Maintenance Therapy with CC-5013 (NSC #703813, IND #70116) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients must have active multiple myeloma requiring treatment and have stable disease or be responsive to at least 2 months of any induction therapy. Must be enrolled within 12 months of last treatment. Peripheral blood stem cell collection may be collected any time prior to transplant |
| Treatment Overview |
Patients will be enrolled onto one of two arms: Pentostatin/TBI without ECP or Pentostatin/TBI with EPC. Patients will then receive a allogenic stem cell transplant. Post treatment, GVHD prophylaxis will be administered. Patients will remain on study until Day 100 post transplant.
The primary endpoint is the incidence of grade 2-4 acute graft versus host disease by day+100 following allogeneic stem cell transplantation in patients randomized to photopheresis vs. no photopheresis. |
2
| Disease Status and/or Stage | Multiple Myeloma |
|---|---|
| Protocol Title | A Phase 1 Pilot Study of a Novel Conditioning Regimen of Bendamustine and Melphalan Followed by Autologous Stem Cell Transplant for Patients with Multiple Myeloma |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. Patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells. |
| Treatment Overview |
As a conditioning regimen, patients will receive Melphalan 100 mg/m2 for 2 days and Bendamustine on the second day of Melphalan. The dose of bendamustine is increased depending on the cohort and toxicity. Autologous hematopoietic stem cells will then be infused. The primary objective of this trial is to determine the safety and toxicity of a Melphalan/Bendamustine conditioning regimen. |
3
| Disease Status and/or Stage | Hematologic Malignancies |
|---|---|
| Protocol Title | A Randomized Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation Versus Pentostatin and Total Body Irradiation in Patients Undergoing Allogenic Stem Cell Transplantation for the Treatment of Hematologic Malignancies |
| PI | Michael Schuster, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients with a diagnosis of a hematologic malignancy and the availability of a suitable 5/6 (Class I mismatch) or 6/6 HLA-matched related or 10 of 10 matched unrelated donor. Patients must be able to receive 600cGy of total body irradiation and adequate protocol specific function tests. |
| Treatment Overview |
Patients will be enrolled onto one of two arms: Pentostatin/TBI without ECP or Pentostatin/TBI with EPC. Patients will then receive a allogenic stem cell transplant. Post treatment, GVHD prophylaxis will be administered. Patients will remain on study until Day 100 post transplant. The primary endpoint is the incidence of grade 2-4 acute graft versus host disease by day+100 following allogeneic stem cell transplantation in patients randomized to photopheresis vs. no photopheresis. |
4
| Disease Status and/or Stage | Peripheral T-Cell Lymphoma - Untreated or Post One Cycle of Chemotherapy |
|---|---|
| Protocol Title | Treatment of Peripheral T-cell Lymphoma with Aggressive Induction Chemotherapy followed by Autologous Stem Cell Transplant using Denileukin Diftitox (Ontak®) for in-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial |
| PI | Rebecca Elstrom, MD |
| Contact | Patricia Glynn, RN 212-746-6738 |
| Key Eligibility |
Histologic diagnosis of any of the following: Peripheral T-cell lymphoma not otherwise specified (PTCL-U) (IPI >2), Angioimmunoblastic T-cell lymphoma (IPI >2), Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma, Extranodal NK/T lymphoma (Excluding stage I/II nasal disease), Blastic NK cell lymphoma, Enteropathy type T-cell lymphoma, Subcutaneous panniculitis-like T-cell lymphoma, Hepatosplenic ?d T-cell lymphoma Patients who test positive for HepBSAg or HepC Ab may be eligible. |
| Treatment Overview | Patients will experience five (5) treatment regimens: Treatment 1: Two 21-day cycles of Gemcitabine, Navelbine, and Doxil. Treatment 2: Two 21-day cycles of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Methotrexate Treatment 3 - Consolidation: Cytarabine, Treatment 4 - Autologous Stem Cell Transplant: Treatment 5 - Post-transplant: Denileukin Diftitox (Ontak®) |
5
| Disease Status and/or Stage | Myelodysplastic Syndrome or Acute Myelogenous Leukemia |
|---|---|
| Protocol Title | A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplantation in Patients with Myelodysplastic Syndrome or Acute Myelogenous Leukemia. |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | The diagnosis of MDS or AML requiring chemotherapy prior to stem cell transplant. Donors must be related or unrelated who are genotypically or phenotypically matched by high resolution HLA typing. |
| Treatment Overview | Patients will be randomly assigned to a myeloablative conditioning regimen (Fludarabine, Busulfan, Cyclophosphamide) or a nonmyeloablative conditioning regimen (Fludarabine + TBI). The post transplant immunosuppression will include will receive Cyclesporine and Mycophenolate Mofetil for the nonmyeloablative patients, and Tacrolimus and methotrexate for the myeloablative patients. |
6
| Disease Status and/or Stage | Chronic GvHD |
|---|---|
| Protocol Title | CALGB 100101: A Phase II Trial of Pentostatin for the Treatment of Patients with Refractory Chronic Graft-Versus-Host Disease |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility |
Histological documentation of chronic GvHD following allogeneic hematopoietic stem cell transplantation (HCT) Failed treatment with or experienced progression after prior corticosteroids for extensive chrnoic GvHD |
| Treatment Overview |
Pentostatin IV over 20-30 minutes every 2 weeks Patients should receive an effective antiemetic 30 minutes prior to each dose of pentostatin Patients should receive prophylactic therapy |
7
| Disease Status and/or Stage | Myelofibrosis |
|---|---|
| Protocol Title | Study of Fludarabine based Conditioning for Allogeneic Stem Cell Transplantation for Myelofibrosis |
| PI | Tsiporah Shore, MD |
| Contact | |
| Key Eligibility | Patient who have a diagnosis of idiopathic myelofibrosis, or spent PV-, or ET-related myelofibrosis in chronic phase are eligible. |
| Treatment Overview | Patients who have sibling related matched donors will receive Fludarabine and Melphalan. Patients who have volunteer unrelated donors will receive Fludarabine, Melphalan, and ATG. |
8
| Disease Status and/or Stage | Autologous Hematopoietic Stem Cell Transplant for Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
|---|---|
| Protocol Title | BMT CTN 0401: Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Tranplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients have persistent or recurrent diffuse large B-Cell lymphoma. Patients must have received 1-3 prior treatment regimens, including an induction chemotherapy and greater than or equal to 2 slavage regimens. |
| Treatment Overview | Eligible patients will be randomized to receive either: 1) Rituxan plus BEAM or 2) Bexxarr/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT. |
9
| Disease Status and/or Stage | Bone Marrow Transplant |
|---|---|
| Protocol Title | Training Patients for HSCT - A Novel Coping Skills Intervention |
| PI | Michael Schuster, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Patients will be receiving a Hematopoietic Stem Cell Tranplant for treatment of hematological malignancies and related diseases. They must have a spouse or partner who has cohabitated with the patient three months prior to tranplant and will serve as a primary caretaker throughout the transplant process. |
| Treatment Overview |
Patients are randomized to address the needs of a bone marrow transplant recipient (and partner/spouse) by examining the benefit of a three-session, couple-focused, telephone-delivered Coping Skills Training (CST) Intervention designed to teach patients and their partners effective coping strategies to manage uncertainty and stressful situations that may arise during the transplant process together. Couples will be randomized to one of two treatment conditions: 1) couple-focused CST plus usual care (Usual care - defined as the care a patient would receive if not enrolled in the study) or 2) Usual Care only. This intervention aims to equip patients & partner/spouse with effective coping skills they can employ individually or together to manage the stressors of transplant and mitigate the likelihood of psychosocial distress. |
10
| Disease Status and/or Stage | Relapsed or Refractory Non-Hodgkin's Lymphoma |
|---|---|
| Protocol Title | NCIC LY.12: A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R)-GDP vs. (R)-DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab vs. Observation |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility | Diffuse large cell lymphoma; previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at relapse; peripheral T-cell lymphoma; anaplastic large cell lymphoma (ALCL); small non-cleaved Burkitt-like lymphoma. |
| Treatment Overview | Salvage Therapy: Maintenance Therapy: |
| Last updated: July 22, 2008 |  |
